On Friday, after years of examination, the US Food and Drug Administration (FDA) released its final environmental assessment for genetically engineered mosquitoes –using Oxitec’s self-limiting OX513A Aedes aegypti mosquito for an investigational trial in the Florida Keys.

The federal regulatory agency concludes:

The FDA has completed the environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s genetically engineered (GE) mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida. After considering thousands of public comments, the FDA has published a final environmental assessment (EA) and finding of no significant impact (FONSI) that agrees with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment.

FDA’s finalization of the EA and FONSI does not mean that Oxitec’s GE mosquitos are approved for commercial use. Oxitec is responsible for ensuring all other local, state, and federal requirements are met before conducting the proposed field trial, and, together with its local partner, the Florida Keys Mosquito Control District, to determine whether and when to begin the proposed field trial in Key Haven, Florida.

Aedes aegypti/CDC

Oxitec’s Chief Executive Officer Hadyn Parry said, “We’ve been developing this approach for many years, and from these results we are convinced that our solution is both highly effective and has sound environmental credentials. We’re delighted with the announcement today that the FDA, after their extensive review of our dossier and thousands of public comments for a trial in the Florida Keys, have published their final view that this will not have a significant impact on the environment. We are now looking forward to working with the community in the Florida Keys moving forward.”

Oxitec’s self-limiting mosquitoes have been genetically engineered so that their offspring die before reaching adulthood. Male Oxitec mosquitoes, which do not bite or spread disease, are released to mate with wild female Aedes aegypti so that their offspring die, reducing the population. Efficacy trials in Brazil, Panama, and the Cayman Islands have tested this approach, and in each of these trials the population of Aedes aegypti was reduced by more than 90% – an exceptional level of control compared to conventional methods, such as insecticides.